NEWSFLASH: FDA Clears Expanded Cartridge t:flex Insulin Pump

If you’re someone who needs more insulin on a daily basis than can be accommodated by a typical insulin pump, then there’s a new diabetes device that could be an option for you!

Say hello to the Tandem Diabetes t:flex insulin pump, just approved by the FDA, that will hold a whopping 480 units of insulin inside — the largest amount of any device on the market to date.

On Monday, Tandem Diabetes announced that the FDA had approved this new larger device (with actualapproval on Jan. 9) — within just 65 days including the holidays since the company filed its paperwork on Nov. 5. That’s significantly shorter than the 90 days it typically takes for this kind of 510(k) submission, in which a new device is pretty much the same as a previously-approved product, with just some minor changes or revisions.

The new t:flex is expected to launch and begin shipping to customers in mid-2015.

So what is the t:flex exactly? It’s pretty much the same as the original t:slim pump from Tandem, but with an expanded insulin cartridge that holds 480 units instead of just 300…

Or, as someone wrote in the diabetes online community post-announcement: “It’s like the Big Gulp of insulin pumps!”

Clearly this t:flex is aimed specifically at those who use a lot more insulin — type 2s, teenagers, and possibly even women who are pregnant and need a higher volume of insulin delivery. Tandem is touting how the t:flex is perfect those who use 100+ units a day, and may therefore find a traditional, smaller pump too cumbersome because they’d have to change cartridges too often.

By comparison, here’s the capacity of other existing insulin pumps on the market:

Animas Ping/Vibe: holds 200 units

Asante Snap: 300 units

OmniPod: 200 units

Medtronic: 180 units or 300 units

Roche Accu-Chek Combo Spirit: 315 units

Tandem t:slim: 300 units

Due to the larger insulin reservoir, the t:flex has an expanded “bump” on the back side (as seen below), which Tandem tells us doesn’t add much in size to the new device but does add a little weight to it overall. Still, it remains smaller than even the current Medtronic 5-series pump that holds 300 units. It also uses different, larger cartridges that are not interchangeable with those used with the regular t:slim.

Image: Tandem t:flex, shown at investor presentation in early 2014

“The basic dimensions are exactly the same,” says Steve Sabicer, a PR rep working for Tandem. “The t:flex cartridge is the only part of the pump that is larger. Tandem will be incorporating the ‘bump’ into future accessories so that even that enlargement is less noticeable. There are also a few minor software tweaks and improvements that will be detailed when the device goes to market, but on the whole the major difference is an expanded cartridge.”

One of those tweaks is that the new t:flex will have a 60-unit max bolus.

We pressed for more detail, but couldn’t get anything more. We also asked about any possible upgrade offers, if someone recently bought the t:slim but wanted the larger t:flex instead… but as of now, there’s no plan for any upgrade of that kind, we’re told.

Tandem expects to launch the t:flex during the second quarter of 2015, so sometime between April and the end of June.

And it will corner the market on highest capacity pump for now, at least until the next-gen OmniPod U-500 patch pump appears on the scene offering a stronger batch of Eli Lilly’s concentrated insulin, ideal for people with highly insulin-resistant type 2 diabetes.

Note that t:flex is the second device for Tandem Diabetes, which debuted its slick t:slim here in the States back in August 2012. And now, we’re anxiously awaiting the next-gen combo device that will integrate the t:slim with the Dexcom G4 CGM. The company submitted that for FDA evaluation in July 2014, and it remains under review.

If all goes as expected, we should see that integrated t:slim-G4 on the market by mid-year, not too long after the t:flex is launched. And that would mean insulin pumpers here in the U.S. will finally have the choice of two different G4-integrated pumps – this new one and the Animas Vibe (just approved in December and beginning to ship out this month). These will both be direct competitors to the Medtronic 530G with Enlite, which was approved in September 2013.

Here’s to more options in the diabetes devices we use, whether we use a whole lot of insulin or not!

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community.
The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines.
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Archived Comments

Doug|2015-01-13

Thanks for announcement

Im curious – shouldn’t this just be a software update to be able to reflect a larger max quantity and larger cartridge ?

Doug

MikeH|2015-01-13

Hey Doug — no, the actual cartridge part of the pump is much larger than the t:slim so it’s a whole new device. But yes, as to the screen showing cartridge insulin and max bolus, those probably are just software updates on the t:flex.

Ellen Cooper RN MSN CDE|2015-01-13

Using U-500 in a pump is hardly “ideal” — it’s a difficult insulin to work with because of its slow onset and long duration of action. IMO, our insulin resistant patients need better concentrated insulins that work more physiologically.

Jeremy Lucas|2015-01-15

So no upgrade path… Hmm. This makes me wonder if I should postpone my order of a t:slim (in Feb) and wait for the t:slim G4. Most companies are offering (Animas Ping to Vibe) upgrade paths when new pumps are released. If this is any indication I may just need to hold on to my aging Vibe and wait till G4 is released.

MikeH|2015-01-15

Jeremy — as of now, Tandem doesn’t have an upgrade path for the t:flex. However, that doesn’t mean they won’t offer one for the t:slim G4 once that’s approved and available.

john|2015-01-15

There is another gotcha with the tflex. It still primes and pumps at the same rate as the tslim. Which is slow esp for a large bolus..question I haven’t gotten answered is does the tflex still stop after so many units of a large bolus and make you double confirm to continue?

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